Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study (NCT04207632) | Clinical Trial Compass
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Quantifying Muscle Tone in Patients With Brain Injury - a Feasibility Study
Denmark5 participantsStarted 2020-04-01
Plain-language summary
This project will determine the feasibility and validity of measuring elbow muscle flexor stiffness in a population of patients with sub-acute severe acquired brain injury using two measurement methods, the portable spasticity assessment device (PSAD) (Movotec, Charlottenlund, Denmark) and an ultrasound measurement called shear wave sonoelastography (SWE).
Who can participate
Age range
5 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Fulfil the normal clinical requirements for treatment with BTX-A in at least one of their elbow flexors, (have increased stiffness in at least one of their elbow flexors, MAS greater than 0),
. Have given the normal informed consent to routine clinical treatment with BTX-A,
. Have given written informed consent or that proxy consent has been obtained, to participate in the study
Exclusion criteria
. Are unable to cooperate with the measurements due to uncontrolled non-voluntary movements
. Cannot be positioned safely or comfortably for the measurements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in resistance to elbow extension measured using the portable spasticity assessment device (PSAD)
Timeframe: Twice at baseline and 4 weeks post BoNT-A injection
2
Change in muscle stiffness in the treated muscle(s) measured using the shear wave elastography (SWE)
Timeframe: Twice at baseline and 4 weeks post BoNT-A injection